Fw: CDERWEEK 3/18 - 3/22/02

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March 22, 2002CDER MaPPs4140.5 Submitting Issues/Documents to the Office of the Chief Counsel (OCC)for Legal Review, Comment, or Clearancehttp://internet-dev/cder/mapp/4140.5.PDF4170.5 Repository Searching in the Division of Information Disclosure Policy(DIDP)http://internet-dev/cder/mapp/4170.5.PDFFrequently Asked Questions to CDERhttp://www.fda.gov/cder/about/faq/default.htmNew and Generic Drug Approvals [includes Drug Label and Approval Letter]http://www.fda.gov/cder/approval/index.htmAnzemet (dolasetron) Injection, Aventis Pharmaceuticals, Inc.Buspirone Hydrochloride Tablets USP, Geneva Pharmaceuticals, Inc.Iopidine (apraclonidine ophthalmic solution), Alcon Laboratories, Inc.Lessina-21 & Lessina-28 (Levonorgestrel & Ethinyl Estradiol) Tablets USP,Barr Laboratories, Inc.Naltrexone Hydrochloride Tablets, Mallinckrodt, Inc.Transderm Scop, Novartis Consumer Health, Inc.Warning and Untitled Letters-2002http://www.fda.gov/cder/warn/warn2002.htmMarch 21, 2002Approved Active Moieties to which FDA has Granted Exclusivity for PediatricStudies under Section 505A of the Federal Food, Drug, and Cosmetic Acthttp://www.fda.gov/cder/pediatric/exgrant.htmDrug Shortages; Current Drug Shortage: Pipracil (piperacillin sodium) Powderfor Injectionhttp://www.fda.gov/cder/drug/shortages/default.htm#CurrentDrug Shortages; Drugs Experiencing Limited Distribution: Zosyn (piperacillinsodium and tazobactam sodium) Powder for Injectionhttp://www.fda.gov/cder/drug/shortages/default.htm#LimitedNew and Generic Drug Approvals [includes Drug Label and Approval Letter]http://www.fda.gov/cder/approval/index.htmAN-DTPA Kit (for the Preparation of Technetium Tc99m Pentetate InjectionDiagnostic for Intravenous Use), CIS-US, Inc.Avinza (morphine sulfate extended-release) Capsules, Elan Drug Delivery,Inc.Lacrisert (Hydroxypropyl Cellulose Ophthalmic Insert) Sterile, Merck & Co.,Inc.Mesnex (mesna) Tablets, Bristol-Myers Squibb.Midamor (amiloride hydrochloride) 5 mg Tablets and Moduretic (amiloridehydrochloride and hydrochlorothiazide) 5/50 mg Tablets, Merck & Co., Inc.Monodox (doxycycline monohydrate) Capsules, Laboratories, Inc.Nicotrol TD (nicotine transdermal system), Pharmacia Consumer HealthcareProAmatine (midodrine hydrochloride) Tablets, Shire Laboratories Inc.TOBI (tobramycin solution for inhalation), Chiron CorporationZocor (simvastatin) Tablets, Merck & Co., Inc.Oncology Tools Update: What's Newhttp://www.fda.gov/cder/cancer/whatsnew.htmMarch 20, 2002Drug Shortage; Drug to be Discontinued: Geref (sermorelin acetate forinjection)http://www.fda.gov/cder/drug/shortages/default.htm#discDrug Shortage; Drug to be Discontinued: Priscoline hydrochloride ampules(tolazoline hydrochloride injection)http://www.fda.gov/cder/drug/shortages/default.htm#discTentative Advisory Committee Meeting Dates as of March 11, 2002http://www.fda.gov/cder/meeting/advisorycomyear.htmPatent Term Extension and New Patents Docket Number *95S-0117http://www.fda.gov/cder/orange/docket.pdfMarch 19, 2002Cumulative Prescription and OTC Drug Product Patent and Exclusivity Datahttp://www.fda.gov/cder/orange/22bookpub.pdfFDA issues Guidance for Industry: Information Program on Clinical Trials forSerious or Life-Threatening Diseases and Conditions. The Guidancehttp://www.fda.gov/cder/guidance/4856.htmEfficacy Supplements Approved in Calendar Year 2001http://www.fda.gov/cder/rdmt/Escy01ap.htmEfficacy Supplements Approved in Calendar Year 2000http://www.fda.gov/cder/rdmt/esap2000.htmEfficacy Supplements Approved in Calendar Year 1999http://www.fda.gov/cder/rdmt/escy99ap.htmEfficacy Supplements Approved in Calendar Year 1998http://www.fda.gov/cder/rdmt/eff98.htmFDA Drug Approvals Listhttp://www.fda.gov/cder/da/da.htmNew and Generic Drug Approvals [includes Drug Label and Approval Letter]http://www.fda.gov/cder/approval/index.htmAcetaminophen Extended-release Tablets, Coerpharma LLCAmpicillin and Sulbactam Injection USP, ESI LederleAsimia (paroxetine mesylate) Tablets, Synthon Pharmaceuticals Ltd.Desonide Lotion, Altana Inc.Timentin (sterile ticarcillin disodium and clavulanate potassium) Injection & Galaxy Plastic Container, GlaxoKlineMarch 18, 2002Information Program on Clinical Trials for Serious or Life-ThreateningDiseases and Conditions

 or [PDF] (Issued 3/2002, Posted 3/18/2002)http://www.fda.gov/cder/guidance/4856FNL.PDFCyber Letters 2002http://www.fda.gov/cder/warn/cyber/cyber2002.htmNew and Generic Drug Approvals [includes Drug Label and Approval Letter]http://www.fda.gov/cder/approval/index.htmErythromycin Topical Gel USP, Glades Pharmaceuticals, Inc.Fludrocortisone Acetate Tablets USP, IMPAX Laboratories, Inc.Mometasone Furoate Ointment USP, Clay-Park Labs, Inc.Sodium Phosphates Injection, USP, Abbott LaboratoriesDRUG APPROVAL PACKAGESAngiomax (bivalirudin) Injection, Drug Approval PackageLantus (insulin glargine [rDNA origin] injection), Drug Approval PackageStarlix (nateglinide) Oral Tablets, Drug Approval Package